Alteplase for Blood Flow Restoration in Hemodialysis Catheters
This study has been terminated.
(Unable to enrol enough people to achieve the full sample size)
Sponsor:
University of Manitoba
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00303420
First received: March 15, 2006
Last updated: December 17, 2008
Last verified: December 2008
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Purpose
We are investigating a new way of administering alteplase to remove clots from hemodialysis catheters. Currently, alteplase is left to dwell inside the catheter between dialysis treatments to dissolve the clot and restore blood flow through the catheter. We have developed a new way to administer alteplase by advancing it to the tip of the catheter at regular 10 minute intervals. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.
| Condition | Intervention | Phase |
|---|---|---|
|
Thrombosis |
Drug: Alteplase "push" protocol Drug: alteplase dwell arm |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Alteplase for Blood Flow Restoration in Hemodialysis Catheters: A Randomized Prospective Clinical Trial |
Resource links provided by NLM:
Further study details as provided by University of Manitoba:
Primary Outcome Measures:
- Proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a "sustainable" post thrombolytic blood flow > or = 300 ml/min. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Highest recorded "sustainable" blood flow (ml/min) pre- and post- thrombolytic administration. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- Change in Kt/V from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
- Change in "litres processed / time" from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
- Serious adverse events including major bleeding within 24 hours of alteplase administration [ Time Frame: 30 days post-last dose ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 180 |
| Study Start Date: | September 2004 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Alteplase used by normal dwell procedure
|
Drug: alteplase dwell arm
alteplase 2 mg / lumen. Instill and let it dwell for 30 minutes. Assess catheter and allow to dwell for a total of 2 hours if necessary
Other Names:
|
|
Experimental: 2
Alteplase given by an new "push" protocol
|
Drug: Alteplase "push" protocol
alteplase 2 mg / lumen. Instill and wait 10 minutes, instill 0.3 ml normal saline, wait 10 minutes, instill 0.3 ml of normal saline, wait 10 minutes and aspirate.
Other Names:
|
Detailed Description:
Central venous catheters are commonly used for vascular access in the hemodialysis population. A common complication is low / no blood flow through the catheter due to clots. These are serious situations because patients may miss dialysis sessions and suffer significant morbidity. In an attempt to dissolve the clots and restore blood flow, thrombolytics are frequently instilled into the catheters between dialysis sessions . However, we have developed and new "push" protocol that advances fresh thrombolytic (alteplase) to the tip of the catheter in order to facilitate more effective and faster removal of the clot. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adults > 18 yrs old
- Hemodialysis patients
- Vascular access with a permanent catheter
- No prior rt-PA use in the catheter over the previous 21 days
- One rt-PA instillation per catheter (i.e. we will only document the results of 1 rt-PA instillation per catheter. Numerous rt-PA instillations in the same catheter will NOT be considered new events, and not entered into the study)
Exclusion Criteria:
- Critically ill patients in the ICU setting.
- Contraindications / cautions with alteplase use including: known hypersensitivity to alteplase or its components (l-arginine, phosphoric acid, polysorbate 80), patients with known conditions associated with bleeding events (e.g.intracranial bleed in last 4 weeks, major hemorrhage in last 4 weeks (Hgb drop of 20 g/L)), recent surgery (<48 hours), recent biopsy (<48 hours), hemostatic defects including severe hepatic disease, or current intracranial / intraspinal neoplasm.
- Hemodialysis catheter has been in the patient less than 14 days.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303420
Locations
| Canada, Manitoba | |
| Brandon General Hospital | |
| Brandon, Manitoba, Canada, R7A 2B3 | |
| St. Boniface Hospital | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Health Sciences Centre | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Seven Oaks Hospital | |
| Winnipeg, Manitoba, Canada, R2V 3M3 | |
| Canada, Ontario | |
| St. Joseph's Hospital | |
| Hamilton, Ontario, Canada, L8N 1Y3 | |
| Grand River Hospital | |
| Kitchener, Ontario, Canada, N2G 1G3 | |
| Thunderbay Regional Health Sciences Centre | |
| Thunderbay, Ontario, Canada, P7B 6V4 | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Canada, Quebec | |
| Maisonneuve Rosemont Hospital | |
| Montreal, Quebec, Canada, H1T 2M4 | |
Sponsors and Collaborators
University of Manitoba
Hoffmann-La Roche
Investigators
| Principal Investigator: | Lavern M Vercaigne, Pharm.D. | University of Manitoba |
| Principal Investigator: | James M Zacharias, MD | University of Manitoba, Internal Medicine, Section of Nephrology |
More Information
Publications:
| Responsible Party: | Lavern M. Vercaigne, University of Manitoba |
| ClinicalTrials.gov Identifier: | NCT00303420 History of Changes |
| Other Study ID Numbers: | B2003:119 |
| Study First Received: | March 15, 2006 |
| Last Updated: | December 17, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Manitoba:
|
catheter hemodialysis dysfunction thrombolytic alteplase |
Additional relevant MeSH terms:
|
Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Tissue Plasminogen Activator Fibrinolytic Agents |
Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents |
ClinicalTrials.gov processed this record on May 22, 2013